PENNSYLVANIA - CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA)

1. Are physicians subject to the CLIA regulations?

Yes. Physicians are subject to CLIA regulations, but only if they have a laboratory as part of their offices. The CLIA amendments were enacted to extend the regulation by the U.S. Department of Health and Human Services (HHS) from the 13,000 laboratories previously regulated by HHS to an estimated 200,000 laboratory sites, including those located in physicians' offices. Generally, CLIA changed the focus of clinical laboratory regulation from regulation based on the type of laboratory site to regulation based on the complexity of the tests performed by a particular laboratory.

All laboratories performing tests on human specimens must register with the Health Care Financing Administration (HCFA). Registration requires a fee ranging from $100 to $600. All laboratories must also submit to a federal inspection every two years, which will result in an additional fee ranging between $300 and $3,100. Laboratories are also subject to a proficiency test three times a year in which their analyses of test specimens will be verified for accuracy. Registration certificates are valid for a maximum of two years or until such time as an inspection can be conducted to determine program compliance, whichever is shorter.

Yes. CLIA regulations apply to all laboratory testing used for the assessment of health or for the diagnosis, prevention, or treatment of disease. CLIA applies to every laboratory and testing site in the United States, even if only a few basic tests are performed as part of physical examinations.

Certain laboratories, however, may obtain a certificate of waiver for a fee of $100 if they can prove that the tests they perform are exempt from specific CLIA requirements. (See following.) These laboratories are nonetheless required to register with HCFA when applying for a certificate of waiver.

3. Which tests are exempt from CLIA requirements?

Eight tests have been designated as exempt from CLIA standards and a laboratory that performs only these tests can obtain a certificate of waiver from CLIA requirements. The eight tests are:

A. Dipstick or tablet urinalysis (non-automated);

B. Fecal occult blood;

C. Ovulation tests using visual color comparisons;

D. Urine pregnancy tests using visual color comparisons;

E. Erythrocyte sedimentation rate (non-automated);

F. Hemoglobin by copper sulfate method (non-automated);

G. Spun microhematocrit;

H. Blood glucose using certain devices cleared by the Food and Drug Administration (FDA) specifically for home use.

Laboratories with certificates of waivers will not be inspected routinely but will still be subject to inspections as part of complaint investigations and on a random basis to determine whether only the waived tests are being performed.

In 1992, HCFA created a new category of procedures which are not subject to routine inspections. The tests include:

A. Physician-performed microscopy procedures including wet mounts, including preparations of vaginal, cervical or skin specimens;

B. All potassium hydroxide preparations;

C. Pinworm examinations;

D. Fern tests;

E. Post-coital direct, qualitative examinations of vaginal or cervical mucous; and

F. Urine sediment examinations.

4. How are laboratories which perform tests not listed on the exempt list regulated?

All tests not listed as waived are divided into one of two categories, moderate complexity or high complexity, based on the complexity of the testing procedure. For these categories, the regulations list specific requirements for proficiency testing, patient test management, quality control, quality assurance, personnel, and inspections.

Some examples of moderate complexity tests are microscopic analysis of urinary sediment, throat cultures, Gram stains, and hematology and chemistry tests conducted on fully automated instruments that do not require operator intervention during the analytic process.

5. What are the major differences between the requirements for laboratories performing tests of moderate and high complexity?

The major differences concern quality control and personnel standards. Personnel standards for facilities doing high complexity testing will require more education and experience than for those doing only moderate complexity testing. The Moderate Complexity classification has requirements for the laboratory director, clinical consultant, technical consultant and testing personnel while the High Complexity classification has requirements for the laboratory director, clinical consultant, technical supervisor, general supervisor and testing personnel.

42 CFR 493.1403-1425; 42 CFR 493.1441-1495

6. How do Pennsylvania's regulations on the operation of clinical laboratories differ from the Federal CLIA regulations?

The Pennsylvania Clinical Laboratory Act (the "Act") is similar in many respects to CLIA in that it covers the same types of laboratories. Yet, certification under the Act has not been deemed as adequate to fulfill the requirements of CLIA. State licensure laws also apply and all Pennsylvania laboratories must acquire a permit to operate from the Pennsylvania Department of Health ("Department").

Under the Act, Pennsylvania utilizes a three tiered system for licensing which is based on the nature and complexity of the tests being performed by the laboratory. Levels I and II are for laboratories performing the simplest tests, while Level III is for laboratories performing the most complex tests. A permit allows the laboratory to perform tests in the licensed category and any tests in a lesser category.

35 P. S. §§ 2151-2165

The Act also establishes minimum qualifications for laboratory staff and procedures for handling samples and for record-keeping.

A. Minimum qualifications for laboratory staff.

1. A director of a clinical laboratory must conform with one of the following requirements:

i. He or she must hold a doctor of science degree or its equivalent in the basic sciences of chemistry, biology or microbiology or a doctoral degree in public health, medicine, osteopathy, pharmacy, dentistry or veterinary medicine from a college or university recognized by the National Committee of Regional Accrediting Agencies or the Department of Education of the Commonwealth of Pennsylvania, and have 2 years' experience in a laboratory acceptable to the Department or be certified by the American Board of Pathology, American Osteopathic Board of Pathology, American Board of Microbiology, American Board of Bioanalysis. American Board of Clinical Chemistry, or other national accrediting board in laboratory specialties acceptable to the Department.

ii. He or she must hold a master of science degree or its equivalent in the basic sciences from a college or university recognized by the National Committee of Regional Accrediting Agencies or the Department of Education of the Commonwealth, in chemistry, biology or microbiology, and have a minimum of 4 years' experience in a laboratory acceptable to the Department.

iii. He or she must hold a bachelor of science degree or its equivalent in the basic sciences from a college or university recognized by the National Committee of Regional Accrediting Agencies or the Department of Education, in chemistry, biology or microbiology, and have a minimum of 5 years experience in laboratory work in a laboratory acceptable to the Department.

In addition, he may be required to pass a written, oral or practical qualifying examination in general laboratory science in one or more of the laboratory categories.

2. Technical personnel must meet the following requirements:

i. A clinical laboratory technologist may perform clinical laboratory tests with minimal supervision by the director or supervisors, while working in those areas in which he or she is qualified by education or experience. A clinical laboratory technologist must have a baccalaureate degree in medical technology or in a chemical, physical or biological science and clinical education in a program accredited by an agency recognized by the Department which includes 1 year of experience acceptable to the Department.

ii. Technical personnel below the level of technologist must be determined by the director to be fully qualified for all assigned technical duties.

28 PA ADC § 5.24

B. Procedures for handling samples.

1. Specimens must be accepted or collected from patients by a clinical laboratory only when tests are requested on the specimens by a member of the healing arts licensed to practice in Pennsylvania, or other persons authorized by statute, or authorized agents of the foregoing.

2. No specimen shall be collected by an owner, an employee or other person associated with the clinical laboratory except under one of the following conditions:

(i) The person is a member of the healing arts licensed in Pennsylvania or a laboratory director.

(ii) The person is collecting the specimen under the direction of a member of the healing arts licensed or a laboratory director.

28 PA ADC § 5.41

C. Record-keeping Requirements.

1. Each clinical laboratory must have a readily available record indicating the daily accession of specimens containing the following information:

i. The laboratory number identifying the specimen.

ii. The identification of the person from whom the specimen was taken. Specimens received by mail shall be accompanied by the name and address of the patient from whom the specimen was taken.

iii. The name and address of the licensed practitioner of the healing arts or other authorized person or clinical laboratory who submitted the specimen. Hospitals may follow their normal procedures associated with requests and records.

iv. The date and hour the specimen was collected by the licensed practitioner or other authorized person.

v. The date and hour the specimen was received in the laboratory and date test was completed.

vi. The condition of the specimen when received that is, broken, leaked, hemolyzed, turbid, satisfactory and so forth.

vii. The analysis performed.

viii. The result of the laboratory test.

ix. The date a required report was sent to the Department or other agencies in accordance with other statutes or provisions.

x. The charges issued to the patient or his authorized agent for the laboratory services performed.

2. All laboratory reports must remain confidential.

28 PA ADC § 5.52; 28 PA ADC § 5.53

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.